Effect of Gui-Lu-Er-Xian-Jiao-Wan on Intradialytic Hypotension

NCT ID: NCT05517993

Last Updated: 2022-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2024-12-31

Brief Summary

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Intradialytic hypotension (IDH), a common complication during hemodialysis (HD) could increase patients' morbidity and mortality. Previous studies considered that some Chinese herbal medicine (CHM) plays a complementary role in reducing the frequency of IDH. This trial is aimed to investigate the effect of Gui-Lu-Er-Xian-Jiao-Wan (GLEXJW) in patients with intradialytic hypotension.

Detailed Description

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Conditions

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Intradialytic Hypotension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Group A

Gui-Lu-Er-Xian-Jiao-Wan (GLEXJW) 3g orally twice daily for 12 weeks.

Group Type EXPERIMENTAL

Gui-Lu-Er-Xian-Jiao-Wan

Intervention Type DRUG

Gui-Lu-Er-Xian-Jiao-Wan (GLEXJW) is an ancient CHM formula, mainly originating from processed tortoise shells, antlers, Ginseng, and wolfberry.

Group B

No intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Gui-Lu-Er-Xian-Jiao-Wan

Gui-Lu-Er-Xian-Jiao-Wan (GLEXJW) is an ancient CHM formula, mainly originating from processed tortoise shells, antlers, Ginseng, and wolfberry.

Intervention Type DRUG

Other Intervention Names

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GLEXJW

Eligibility Criteria

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Inclusion Criteria

* End stage renal disease treated with hemodialysis for ≥3 months
* Receive a standard thrice-weekly hemodialysis schedule
* More than 25% of hemodialysis sessions complicated by intradialytic hypotension

Exclusion Criteria

* Active malignancy
* Life-threatening conditions
* Pregnancy
* Recent participation in another clinical trial for intradialytic hypotension
* History of hypersensitivity or contraindication to herbal medicine
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chun-Ting Liu

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Locations

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Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Site Status

Countries

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Taiwan

Central Contacts

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Chun-Ting Liu

Role: CONTACT

+88677317123

Other Identifiers

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CMRPG8M0841

Identifier Type: -

Identifier Source: org_study_id

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